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2022 Stakeholder Meeting 

Questions and Answers

Chat Box questions that were not answered during the meeting

How much of the genome is examined when applying for exemption? Is there any oversight of the 

genome for anything outside the trait being inserted?

Answer: For part 1 of the question, generally the entire genome (or known genome) is subject to 

examination for the retention of exogenous DNA sequences or secondary targets, though whether 

retention of any exogenous DNA sequences is intended or unintended is dependent on the exemption 

being claimed. For part 2, again the entire genome (or known genome) is subject to examination for 

unintended modifications.

Subray mentioned that 10 more staff members were hired in the last 2 years. And I thought I heard 

him say that they also hired 5 more recently. How many new hires in BRAP have been brought on 

since the revised regulations were implemented vs. how many employees have left since that time? 

How many analysts/biotechnologists are there currently in BRAP? Does BRAP have a hard time finding 

candidates with the appropriate qualifications and skills for the job?

Answer: Since March 2020, 15 staff members have joined BRAP and 4 staff members have departed. 

Excluding supervisors, BRAP presently has 25 staff members who are biological scientists or 

biotechnologists who support permitting applications, Confirmation Requests, and Regulatory Status 

Review requests. For certain practice areas, we have had challenges building well-qualified candidate 

pools and have overcome this recently by enhancing and expanding recruitment efforts with

universities, professional organizations, and scientific publications.

Did Subray say that plants modified for pharmaceutical, or phytoremediation were not eligible for the 

RSR process?

Answer: The permitting provision in the regulations specifies that “a plant that encodes a product 

intended for pharmaceutical or industrial use” may not be imported, moved interstate, or released into 

the environment without a permit. 7 CFR 340.2(e). Plants engineered to produce industrial compounds 

include those plants that meet the following three criteria: (1) The plants are engineered to produce 

compounds that are new to the plant; (2) the new compound has not been commonly used in food or 

feed; and (3) the new compound is being expressed for non-food, non-feed industrial uses. 70 Fed. Reg. 

23009 (May 4, 2000).

If there is time, can the 1st panel group confirm that there are 34 RSR's submitted? does this include 

only those that are technically complete or is it all of them that are submitted?

Answer: As of December 8, 2022 (the date of the stakeholder meeting), BRS held 34 active Regulatory 

Status Review requests. 

BRS committed in the preamble of the Part 340 final rule that they would publish a list of taxa 

containing plant pests on its website. When will BRS release its list of taxa of plant pests? What has 

been holding up its release?

Answer: Given the level of other work currently underway, BRS expects to publish a list of taxa in fiscal 

year 2024.
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Will the Guide for microbe permit applications be issued as a draft and then open for public comment? 

Answer: Yes. BRS will seek public feedback on the draft Guide for Submitting Permit Applications for 

Modified Microorganisms. BRS anticipates making this draft Guide available for review and comment in 

Spring 2023.

Question: Please explain why we proceed with deregulating traits vs. labeling and tracking this new 

technology... as we can see that this is going to be a major hurdles when it comes to international 

trading in the future.

Answer: The Animal and Plant Health Inspection Service administers 7 CFR part 340, promulgated using 

authority from the Plant Protection Act, to ensure that certain organisms developed or modified using 

genetic engineering are safe for plant health and agriculturally important resources. In contrast, the 

Agricultural Marketing Service administers the National Bioengineered Food Disclosure Standard, which 

is promulgated under the amended the Agricultural Marketing Act of 1946, to establish a standard for

disclosing any food that is or may be “bioengineered” (as defined by Congress). As a whole, when 

engaging with international partners, USDA works to promote science-based decisions for international 

trade of all agricultural products. In this regard, APHIS supports the efforts of the Foreign Agricultural 

Service to build a level playing field for U.S. agricultural products with trading partners and we, at BRS,

engage with our regulatory counterparts to explain APHIS regulations and decision-making.

Given the direction in the US towards problem formulation as a part of the exemption/not subject to 

regulation process, this moves away from a process-based trigger for regulation common in other 

jurisdictions. To what extent is this specifically stressed in international discussions?

Answer: BRS has reached out to many countries both one-on-one and in multi-lateral forums to 

describe our revised regulations, including the scientific underpinnings for modified plants that are 

exempt from regulation and the process we use when conducting a Regulatory Status Review. During 

these conversations, we always explain that one of the goals of the revised regulations is to focus on the 

characteristics of the product and not the method used to produce it.

Are there discussions with USDA-AMS regarding aligning technical definitions regarding the National 

Bioengineered Food Disclosure Standard (such as, for instance, what "cannot be created through 

conventional breeding or found in nature" on a technical level in BRS's view vs. AMS's view?)

Answer: Yes.

If the PPRA finds a scientifically credible plant pest risk, but also finds a benefit to plant health that 

might outweigh the impact posed by the plant pest risk, what decision will the agency make?

Answer: Under the Regulatory Status Review process, we consider whether a modified plant may 

plausibly pose a pathway to increased plant pest risk relative to an appropriate comparator (generally a 

non-modified plant of the same species). If BRS determines a plant is unlikely to pose an increased plant 

pest risk relative to a comparator, the plant is not subject to the regulations. In the context of this 

review, BRS’ evaluation focuses on plant pest risk.